Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

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Lower Court Agrees With WuXi AppTec (And Many Of Us)

A lower-court ruling does not make a victory. But it adds a little sanity to this melodrama. On August 7, a U.S. District Judge did something that has been surprisingly rare in the long-running WuXi AppTec/BIOSECURE Act saga: He looked at the U.S. government's case for labeling WuXi a “Chinese military company” and decided the government had not shown enough evidence. Analysis from Chief Editor Louis Garguilo.

GUEST COLUMNISTS

Are Biopharma Companies Outsourcing Their Ability To Think?
Amid gaining immediate access to external manufacturing capabilities, sponsor companies can lose the foundational understanding required to govern that capability.
June 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
The Decision Rights Matrix: Making Sponsor-CDMO Governance Enforceable
In LVV manufacturing, the quality target product profile and the DRM are designed to work together. One defines what is being governed, the other names who governs it.
Defining Quality In A Sponsor-Owned QTPP Before The CDMO Even Starts
Version-controlled quality target product profiles, authored by the drug sponsor, close any gaps between the CDMO's and sponsor's definitions of quality.
Reshoring Pressure Meets Manufacturing Reality
U.S. pharma can't reshore what domestic capacity can't absorb. Senior leaders from Takeda, Biogen, Eli Lilly, and others reveal why tariff pressure is colliding with a sterile fill-finish shortage, workforce gaps, and ADC capacity bottlenecks.
CDMO Live Europe 2026: Partnerships For An Uncertain World
112 pages of executive insight from CDMO Live Europe 2026: tariffs, geopolitics, supply resilience, AI in manufacturing, and why strategic partnerships remain aspirational for most.
Resilience, Risk, And Relationships: CDMO Live Europe 2026 Report
Senior pharma leaders from Pfizer, Bayer, BioNTech and others debunk dual sourcing myths and reveal what separates strategic CDMO partnerships from transactional ones.
Demonstrating Non-Inferiority Of BFPCs Vs. Traditional Air Monitoring
Demonstrating non-inferiority of bio-fluorescent particle counter (BFPC) technology to traditional active air-sampling methods is essential for implementation. Here's how to approach it.

PHARMA OUTSOURCING WHITE PAPERS

Where Innovation And Investment Reduce Drug Development Risk
How strategic investments in development, manufacturing, and clinical supply are helping organizations reduce risk and accelerate drug development.

FDA's Regenerative Medicine Advanced Therapy (RMAT) Program
RMAT qualification requires preliminary clinical evidence demonstrating the potential to address an unmet medical need. This designation grants benefits like intensive guidance and faster FDA review.
Open-Label Study Assessing Relative And Absolute Bioavailability
Consistent absorption across different formulations and dietary conditions ensures stable therapeutic exposure. This flexibility simplifies patient dosing schedules and supports manufacturing transitions.
Advances In High-Concentration Protein Formulation Development
High-concentration protein formulations improve patient convenience but face challenges like viscosity, aggregation, and surfactant degradation. Innovative strategies optimize stability, scalability, and quality for advanced biologics development.
Why Tailored CDMO Support Is A Non-Negotiable In Sterile Fill-Finish
Modern injectable programs require adaptable manufacturing strategies. Learn how flexibility, technical depth, and collaboration reduce complexity, manage change, and protect long‑term supply.
Application Of Plant And Process Models
Explore innovative process and facility models that optimize efficiency, sustainability, and cost-effectiveness in biopharmaceutical manufacturing.